Parenteral fluid container and port structure



Se t. 14, 1965 J. E. ALDER ETAL 3,205,889

PARENTERAL FLUID CONTAINER AND PORT STRUCTURE 5 Sheets-Sheet l FiledJuly 23, 1962 a fi g PARENTERAL FLUID CONTAINER AND PORT STRUCTURE FiledJuly 23, 1962 Sept. 14, 1965 J. E. ALEDER E'E'AL 5 Sheets-Sheet 2 FIGQPARENTERAL FLUID CONTAINER AND PORT STRUCTURE Filed July 23, 1962Sept.'14, 19% J. E. ALBER ETAL 5 SheetsSheet 3 FiG'IO PIC-3.11

Geyemfl llgeaf J. E. ALQER ETAL Sept. 14, m5

PAP-.EEQEERAL FLUID COE'TAIETER AND PO51? STRUCTURE Filed July 25, 1962Sept. 14, 1965 J. E. ALQER FETAL gygfisaggg PARENTERAL FLUID CONTAINERAND PORT STRUCTURE 5 Sheets-Sheet 5 Filed July 25, 1962 United StatesPatent 3,205,889 PARENTERAL FLUID CONTAINER AND PGRT STRUCTURE James E.Alder, Grayslake, and Glenn L. Beat], Wildwood, Ill., assignors toAbbott Laboratories, North Chicago, 'Ill., a corporation of IllinoisFiled July 23, 1962, Ser. No. 211,568 8 Claims. '(Cl. 128-272) Thisinvention relates to a bag having at least one port assembly.

In the prior art, a bag which is employed in the administration of aliquid parenteral solution generally has at least one port assembly.Liquid communication from the bag to the patient is established by atube which is normally connected at one end to a port assembly on thebag and at the other end to a hypodermic needle. The tube is eitherintegrally connected directly to the port assembly or the tube issuitably connected by a connector to the port assembly of the bag by theuser shortly before use. A bag which is employed to collect blood from adonor is conventionally provided with a donor tube which is normallyconnected at one end to a port assembly on the bag and at the other endto a hypodermic needle. After the blood has been collected from thedonor through the donor tube, the donor thbe is clamped off or knottedsince by this time the donor tube has fulfilled its function. In themain, the blood, termed whole blood, is administered to a donee withoutcentrifuging to separate the plasma and red cells, although in the eventit is desired to administer either plasma or red cells, the whole bloodis centrifuged. Then either the plasma or the red cells are extractedthrough another port assembly on the bag. The bag is then ready to beemployed to administer either the plasma or the red cells whichever bychoice remains in the bag after the extraction. Generally then, a bagwhich is employed for the collection of blood and the administration ofwhole blood, plasma or red cells has one more port assembly than a bagwhich is employed for the administration of a parenteral solution. Itwill be readily apparent that some of the features of the invention areespecially useful in connection with bags which are adapted to contain aliquid such as Whole blood, plasma or red cells, While the same featuresare also useful in a bag which is adapted to contain a liquid such as aparenteral solution.

In accordance with one of the features of the invention, the portassembly preferably has a tubular body and a flexible port flangesecured at the transverse end of the bag wall. The port flange is ofsufficient longitudinal extent and flexibility to provide a fingershield so that when a piercing pin is inserted through the port assemblyand the bag wall, the piercing pin will not pass through both the bagwall and the port flange to injure a finger of the user. It is preferredto provide the port flange with one or more projections which serve bothto stiffen the port flange and to provide a roughened surface forfacilitating the gripping of the bag.

In accordance with another feature of the invention there is provided aclosure for a port assembly which has formed integrally therewith asupporting member which supports the bag wall at the diaphragm.

In accordance with another feature of the invention, there is provided aport assembly which is secured to a transverse end of the bag, the bagwall of the bag defining a chamber which is substantially free of air. Atube, for example, specifically a donor tube, is received by the portassembly and it extends into the chamber, the terminal end of the tubedefining a drop former. The port assembly has a port flange whichprovides sufiicient stiffness to maintain the bag wall at thattransverse end in a spacedapart relationship.

r: CC

It is another feature of the invention to provide a closure for the portassembly which has a closure flange retained in seating engagement withthe port flange. The closure is of a character to be removable from theport assembly but is incapable of being reseated against the portflange.

It is another feature of the invention to provide means in addition to aretainer for preventing the closure flange from being unseated from theport flange during the centrifuging of the liquid, for example blood,contained in the bag.

In connection with a port assembly which is employed to fill orpartially fill the bag with a liquid such as an anticoagulant through atube which is received by the port assembly, there is provided a closurehaving means for assisting both the insertion into and withdrawal of theclosure from a marginal end of the tube.

In accordance with another feature of the invention there is provided ahanger assembly whereby the bag is supportable. The hanger assembly issecured at its ends to each port assembly, the port assemblies providinga reinforcement of the bag at space-d intervals. In addition, the hangerassembly provides a retainer for retaining the closure flange of theclosure seated against the port flange of the port assembly.

In accordance with another feature of the invention there is provided aclosure having a portion thereof sealed to the port flange. The closureserves to retain that portion of the port assembly and diaphragm formedby the bag wall through which .a piercing needle is adapted to pass, ina sterile condition. The closure fits over the terminal end of the portassembly. The closure has a rupturable portion which is spaced from theterminal end of the port assembly. The ruptura-ble portion enables theone portion of the closure to be separated from the other portion of theclosure at the rupturable portion, thereby exposing the terminal end ofthe port assembly.

. In accordance with another feature of the invention, there is providedfor a bag having a flexible bag wall, the bag wall having a pair oftransverse ends terminating at a pair of longitudinal marginal sides. Aport assembly is disposed at one transverse end near one longitudinalmarginal side. The one transverse end having the port assembly extendingobtusely and obliquely from the one longitudinal marginal side to theother longitudinal marginal side which is disposed nearer the portassembly. It is therefore readily apparent, that during the extractionof the plasma from the red cells, for example while the bag is in anextractor, the last traces of plasma are con- [fined to one corner ofthe blood bag. This feature also facilitates efficient drainage of thebag when the liquid to be administered is whole blood, plasma, redcells, a parenteral solution or the like.

By an alternative construction, the transverse end of the bag is of acharacter to be disposed generally perpendicularly to the longitudinalmarginal sides. In the event that it is desired to confine the lasttraces of for example the plasma to near one of the port assemblies asit is during the extraction of the plasma from the red cells, a pair ofspaced hangers are empl-oyable, the effective extents of which areunequal. One manner of bringing this into accomplishment is to provide ahanger assembly having a pair .of hangers, the ends of which areconnected to a port assembly. In this case, one of the hangers is longerthan the other of the hangers so that the bag hangs canted with respectto the horizontal. Another manner of accomplishing this purpose is toprovide apertures at each of the opposed longitudinal marginal sideswhich are disposed at unequal effective levels or extents from theterminal end of the bag having the port assemblies.

spon es -In the diagrammatic, illustrative drawings:

FIGURE 1 is a side elevation view, partly cutaway, showing the bag ofthe invention;

FIGURE 2 is a fragmentary view showing three port assemblies arranged onthe web of flexible material;

FIGURE 3 is a perspective view showing a hanger assembly of oneembodiment of the invention;

FIGURE 4 is a fragmentary view showing the manner in which the hangerassembly is disposed in relationship to the port assemblies;

FIGURE 5 is an enlarged fragmentary view showing the manner in which aclosure is disposed in a marginal end of .a tube;

FIGURE 6 is a fragmentary view, mainly in crosssection, showing themanner in which a piercing needle is adapted to enter a diaphragm in thespread-apart bag wall through a port assembly;

\FIGURE 7 is a fragmentary view, mainly in crosssection, showing aclosure of one embodiment of the invention and the manner in which it isseated against a port flange of the port assembly;

FIGURE 8 is a side elevation view of the bag of the invention shown inconjunction wit-h conventional administration equipment;

FIGURE 9 is a fragmentary perspective view showing one manner ofextracting the plasma from the red cells in the bag of the invention;

FIGURE 10 is a fragmentary view, partly in crosssection, showing amanner in which a closure is adapted to be inserted into and withdrawnfrom a marginal end of a tube which is received by the port assembly;

FIGURE 1 1 is a fragmentary view, mainly in crosssection, showing amarginal end of a tube extending into a chamber defined by a bag wall ofthe bag and showing a closure disposed in the marginal end of the tubewhich lies in the chamber beyond the bag wall;

FIGURE 12 is .an alternative form of closure from that illustrated inFIGURES 10 and 11;

FIGURE 13 is still another alternative form of closure from thatillustrated in FIGURES 10, 11 and 1 2;

FIGURE 14 is a cross-sectional side elevation view of an alternativeform .of closure in accordance with the invention;

FIGURE 15 is a side elevation view, mainly in crosssection, showing amold wherein the closure shown in FIGURE 14 is adapted to be molded;

FIGURE 16 is a fragmentary perspective view of the closure shown inFIGURE 14 shown attached to a retainer of the hanger assembly;

FIGURE 17 is a fragmentary view, partly in crosssection, showing themanner in which one portion of the closure of FIGURE 14, for example, isremovable from the other portion of the closure;

FIGURE 1 8 is a perspective View of an alternative form of closure likethat shown in FIGURES 14, 16 and 17, but having a roughened outersurface;

"FIGURE 19 is a fragmentary view showing the bag of the invention havingan alternative form of hanger assembly, whereby a transverse end of thebag having a .port assembly is adapted to be hung canted with respect tothe horizontal in an extractor;

FIGURE 20 is a side elevation view of an alternative form .of hangerassembly having a pair of spaced hangers with apertures there-in, .atleast one aperture in one hanger being disposed at a different levelwith respect to an aperture in the other of the hangers by which atransverse end of the bag having at least one port assembly is adaptedto be disposed canted with respect to the horizontal;

FIGURE 21 is a side elevation view, partly broken away, showing analternate construction whereby a transverse end of the bag is adaptedselectively to be canted with respect to the horizontal;

Referring now to FIGURE 1 of the illustrative drawings, there is shown asubstantially rectangular bag 25 which is adapted to contain a liquid,for example an anticoagulant A. The bag 25 is composed of a flexiblematerial which is compatible with the liquid adapted to be containedtherein. The bag 25 has a bag wall 2 5a which is shown to have a pair ofopposed transverse ends 26 and 27 which terminate at opposedlongitudinal marginal sides 28 and 29. The bag wall 25a defines achamber 25b in which the liquid is adapted to be contained. A trans-Verse seal 30 at the transverse end 27 is shown to join longitudinalseals 31 and 32 at the longitudinal marginal sides 28 and 29,respectively. Within the transverse seal 30 there is disposed anaperture 33 near the longitudinal seal 31, an aperture 34 near thelongitudinal seal 32, and an elongated aperture 35 between the apertures33 and 34. A port assembly 36 is shown'to be disposed at the transverseend 26 near the longitudinal marginal side 28, while a port assembly 37at the transverse end 26 is shown to be disposed near the longitudinalmarginal side 29. A :port assembly 38 is shown to be disposed betweenthe port assemblies 36 and 37' at the transverse end 26 of the bag 25.The transverse end 26 of the bag wall 25a is shown, for example inFIGURE 6, to have a generally U-shaped configuration.

In the event the bag 25 is to contain a parenteral solution, it isobvious that only one port assembly such as the port assembly 36 need beprovided.

As best shown in FIGURE 5 of the illustrative drawings, the portassembly 38 is shown to include a tubular body 39 and a port flange 40which is formed integrally therewith. The port flange 40 is suitablysecured for example by dielectric sealing or chemical sealing to thetransverse end 26 of the bag wall 25a. Each port flange 40 is preferablyprovided with one or more projections 40:: which help to hold the bagwall 25a, at the transverse end 26, spaced-apart, in the event the portflange 49 is too thin or flexible to adequately accomplish this purpose.By the employment of dielectric sealing it is convenient to extrude theprojection 49a from the port flange 4d during the dielectric sealing ofthe port flange 40 to the bag wall 25a. Extruding the projections 40a atthe time of sealing the port flange 40 to the bag wall 25a enables theseal to be made which is bubble-free, that is, no air bubbles are formedbetween the bag wall 25a and the port flange 40. Also, the projection40a stiilens the port flange 46 so that the bag wall 25a is held in aspacedapart relationship. A tube 41 is received in the tubular body 39of the port assembly 33 and it extends slightly beyond the bag wall 25a.The tube 41 is sealed in the tubular body 39 by chemical scaling forexample.

The port assemblies 36 and 37 are similar to each other in constructionas is readily apparent from FIGURES 1, 2 and 4 of the illustrativedrawings and hence like reference characters are employed to designatelike components. The port assembly 36 and the port assembly 37 each areshown to have a tubular body 42 and a port flange 43. Each port flange4-3 is shown to have a pair of enlarged portions 44 and 45 which have asufiicient longitudinal extent, thickness and flexibility to provide aprotective finger shield. Each port flange 43 enables the transverse.end 26 of the bag wall 25a to have a generally U-shaped configurationeven though each port flange 43 is composed of a flexible material. Eachport flange 43 is preferably slightly more rigid, although stillflexible, than the bag wall 25a. Each port flange 43 is preferablyprovided with one or more upstanding projections 43a which serve thedual function of stiflening the port flange 43 and of roughening thesurface of the port flange 43 to facilitate the gripping thereof. By theemployment of dielectric sealing, it is convenient to extrude theprojections 43a from the port flange 43 during the dielectric sealing ofthe port flange 43 to the bag wall 25a. Extruding the projections 43:;at the time of sealing the port flange 36, for example, to the bag wall25a enables a seal to be made which is bubble-free, that is, no airbubbles are formed between the bag wall 25a and the port flange 43'. Theprojections 43a on the port flange 43 also enable the user to grip theenlarged portions 44 and 45 quite easily when a piercing needle isemployed to pierce a port diaphragm 25c which forms a part of the bagwall 25a. It is to be understood that the port flange 43 will flexsomewhat when grasped between the thumb and the index finger of one handof the user during the insertion of the piercing needle. The port flange43 also serves to prevent the bag wall 25a from tearing beyond the placeof the port diaphragm 250.

A hanger assembly 46, which is shown to have a pair of hangers 46a and46b, is provided for supporting the bag 25. As best shown in FIGURE 3 ofthe illustrative drawings, the hanger assembly 46 is shown to be a stripof flexible material 47 having retainers 48 and 49 at opposed ends and acentral retainer 50. The retainers 48 and 50 are considered to form theopposed ends of 48 and 5t) areconsidered to form the opposed ends of thehanger 46a, while the retainers 49 and 50 are considered to form theopposed ends of the hanger 46b. Inwardly of peripheral marginal edges 51and 52 of the retainers 48 and 49 there are provided upstanding marginalflange portions 53 and 54 which define apertures 55 and 56,respectively. The retainer 50 has a central aperture 57. The retainers48, 49 and 50 are received by the tubular bodies 42, 42 and 39 of theport assemblies 36, 37 and 38, respectively. The retainer 50 is securedat its entire undersurface to the port flange 40 of the port assembly 38while only the peripheral marginal edges 51 and 52 of the retainers 48and 49 are secured to the port flanges 43 of the port assemblies 36 and37, respectively.

As best shown in FIGURE 7 of the illustrative drawings, there is shownthe port assembly 36 (which is identical to the port assembly 37)provided with a closure 60 having a closure body 61 and closure flange62 formed integrally therewith. The retainer 48 overlies and is inabutment with the closure flange 62, while the closure flange 62overlies and is in abutment with the port flange 43. The retainer 48serves to hold the closure 60 seated against the port flange 43. Theclosure flange 62 is, therefore, locked between the retainer 48 and theport flange 43. The upstanding marginal flange portion 53 embraces aportion of the closure body 61 of the closure 69. A resilient ring 63which is shown to be of somewhat greater width than the upstandingmarginal flange portion 53 urges the upstanding marginal flange portion53 in hoop compression against a portion of the closure body 61 of theclosure 60. The resilient ring 63 is preferably composed of rubber butother resilient materials suitable for the purpose are employable. Theprimary purpose of the ring 63 is to insure that there is no possibilitythat the closure 60 will be unseated during centrifuging in the eventthat the bag 25 is to serve as a blood bag and during sterilization inthe event the bag 25 is to serve as a solution bag, but the resilientring 63 also improves the seal between the retainer 48 and the closure60 to maintain sterility and prevent leakage during any and allhandling. The closure body 61 has formed integrally therewith aninwardly projecting supporting member 61a which has an outside diameterwhich is less than the inside diameter of the tubular body 42 to provideclearance for removing the closure 60 from the port assembly 36 (or 37 Aterminal end 61b of the supporting member 61:: is shown to be insupporting contact with the portdiaphragm 25c. When the port flange 43is placed on the bag wall 2517 with the closure 60 in place, theterminal end 61b of the supporting member 61a is spaced from the bagwall 2511. When the port flange 43 is sealed to the bag wall 25b and theextrusions 43a are made and completed, the terminal end 61b of thesupporting member 61:: just contacts the diae phragm 25c of the bag wall25a. The purpose of the supporting member 61a is to prevent the portdiaphragm 25c from flexing or bulging outwardly to form a dimple duringcentrifuging, autoclaving or the like. Such a dimple would serve toweaken the bag wall 25a at the diaphragm 25c. When it is desired toremove the closure 60, the closure body 61 is grasped for example by thethumb and index finger of one hand of the user. When a bending followedby a pulling force is exerted on the closure 60, the retainer 48 and theclosure flange 62 each flex to enable the closure 66 to be removedthrough the aperture to beyond a terminal end 42a of the tubular body42. The resilient ring 63 remains embraced on the closure body 61. Theretainer 48 and the closure flange 62 are made suitably flexible forthis purpose. If desired, a relatively rigid closure flange 62 isemployable provided that the retainer 48 has sufficient flexibility toenable the closure flange 62 to flex the retainer 48 sufliciently topermit the removal of the closure 66. Conversely, the retainer 48 is ofa character to be made relatively rigid and in that event a moreflexible closure flange 62 is provided. The projections 43:: assist theuser in gripping the port flange 43 during the removal of the closurefrom the tubular body 42. Once the closure flange 62 has been removedout of seating engagement with the port flange 43 to beyond the retainer48, the closure flange 62 canot be reseated against the port flange 43.It is therefore readily apparent that the retainer 48 makes the closure60 tamper-proof. It is also readily apparent that the hanger assemblyserves a dual function of providing a pair of hangers 46a and 46bwhereby the bag is supportable and it also serves to retain the closuresin seating engagement with the port flange.

As best shown in FIGURE 10 of the illustrative drawings there is shown aclosure generally indicated at 64 which is disposed at the marginal end65 of the tube 41. The closure 64 is shown to have a spherical closureportion 66 and a handle portion 67 which extends into the chamber 25bdefined by the bag wall 25a as is shown in FIGURES 10 and 11 of theillustrative drawings. The handle portion 67 of the closure 64 enablesthe user to insert the spherical closure portion 66 of the closure 64into the marginal end 65 of the tube 41 to close off communicationbetween the chamber 251) and tube 41 and it also enables the user towithdraw the spherical closure portion 66 0f the closure 64 from themarginal end 65 of the tube 41. In the event that there is liquid in thechamber 25b the closure 64 prevents the liquid from escaping into thetube 41. The bag wall 25a is sufliciently flexible to enable the bag tobe wrinkled locally as indicated in FIGURE 10 so that the closure 64 canbe easily inserted into and withdrawn from the marginal end 65 of thetube 41.

As best shown in FIGURE 11 of the illustrative drawings the marginal end65 of the tube 41 preferably extends beyond the bag wall 25a into thechamber 25b. The portion of the marginal end 65 which extends beyond thebag wall 25a is preferably made sufliciently long to enable theeffective place of closure to be made beyond the bag wall 25a in thechamber 25b. In the event that the spherical closure portion of theclosure 64 is inserted into the marginal end 65 of the tube 41 to theplace where the port assembly 38 surrounds the spherical por- .tion 66as shown in FIGURE 5 of the illustrative drawings, added resistance toinsertion of the closure 64 is encountered due to the fact that thespherical closure portion 66 is forced to expand not only the marginalend 65 of the tube 41 but also the tubular body 39 of the port assembly38. In the embodiment of FIGURE 11 of the illustrative drawings thespherical portion 66 can be slightly larger with respect to the insidediameter of the marginal end 65 of the tube 41 than in the embodiment ofFIGURE 5 of the illustrative drawings due to the fact that only themarginal end 65 of the tube 41 need be expauded. Before the closure 64is inserted into the marginal end 65 of the tube 41 and after theclosure 64 has been removed therefrom, the closure 64 simply remains 7in the chamber 25b as shown in phantom in FIGURE 1 of the illustrativedrawings.

A terminal end 65a of the tube 41 defines a drop former during thecollection of blood from a donor. The port flange 40 with its projection40a is of sufficient extent and provides sufficient stiffness to thetransverse end 26 of the bag wall 25a to maintain the transverse end 26of the bag Wall 2511 in a spaced-apart relationship. The port flange 41)maintains the bag wall 25a at the transverse end 26 spaced-apart eventhough the chamber 25b defined by the bag 25 is substantially free ofair. It is therefore readily apparent that the user is able to determineat a glance whether or not blood is still flowing through the tube 41from the donor.

FIGURE 12 of the illustrative drawings illustrates an alternative formof closure generally indicated at 64A having a closure portion 66a and ahandle portion 67a. A tapered end 661) of the closure portion 66::facilitates the insertion of the closure portion 66a into the marginalend 55 of the tube 41, while roughening, which is shown to be in theform of circumferential grooves 72, insures better gripping engagementwith the handle portion 67a.

FIGURE 13 of the illutsrative drawings illustrates still anotheralternative form of closure generally indicated at 6413. A handleportion 671) has a spherical closure portion 66c and 66d at each end.Two closure portions 660 and 66d are provided so that the closure 6413will not have to be rotated more than 90 degrees before its insertioninto the marginal end 65 of the tube 41. It is readily apparent thateither the closure portion 660 of the closure portion 66d is employableto close off communication between the chamber 25b and the tube 41.

Referring now to FIGURES l, 8 and 9 of the illustrative drawings, thebag 25 is shown to have its transverse end 26 extending obliquely andobtusely from the marginal side 28 to the marginal side 29. Thetransverse end 26 makes an obtuse angle with the marginal side 28, whilethe transverse end 26 makes an acute angle with respect to thelongitudinal marginal side 29. The longitudinal marginal sides 28 and 29and their longitudinal seals 31 and 32 are disposed gene-rally parallelto each other. There is shown in FIGURE 9 of the illustrative drawings afragmentary portion of an extractor generally indicated at 73 of a typeshown and described on page 43 of the publication The Use of Bloodpublished in 1961 under the direction of Abbott Laboratories. Theextractor 73 has a fixed plate 7 3a and a movable plate 73b which isadapted to exert pressure on the bag 25. The bag 25 is hung by thehanger assembly 46 on hooks 75 and 76 of equal height after the redcells RC, for example, have been separated from the plasma P during thecentrifuging. The blood in the bag 25 is centrifugable so that theplasma P is at the upper end of the bag while the adjacent red cells RCare at the lower end of the blood bag, or vice versa. Throughout thediscussion, it will be assumed that the plasma P is in the upper portionof the bag 25. A bag 25A identical to the bag 25 is supported by itshanger asembly 46a on hooks 75a and 76a. A tube 41a is connected at oneend to a port as sembly 38a which is identical to the port assembly 38,while the tube 41a is connected at the other'end by a piercing needle37A to the port assembly 37. As the movable plate 73b is moved towardthe fixed plate 73a of the extractor 73, the red cells RC act upon theplasma P so that eventually the last traces of the plasma are confinedto that portion of the bag 25 which is closely adjacent the portassembly 37. In this manner it will be assured that effective transferof the last traces of the plasma P into the bag 25A from the bag 25 isaccomplished.

When for example the red cells RC are ready to be administered to thepatient, the bag 25 is supported by a hook 79 which passes througheither the aperture 35 or the aperture 33 when the port assembly 37 isemployed to serve as the port assembly through which, in this case, thered cells RC pass to the patient. When the port assembly 36 is to beemployed, the hook 79 is passed through the aperture 34 to facilitateetficient drainage of the bag 25 of the red cells RC, and a piercingneedle 80 is passed into the tubular body 42 to pierce the portdiaphragm 250 in the wall 25a. The piercing needle 80 is frictionallyheld in place by the tubular body 42. The piercing needle 80 isconnected to a drip chamber 81 which has a filter 82. A length of tubing83 is connected at one end to the drip chamber 81 and at the other endto a hypodermic needle 84. A tubing clamp 85 along the tubing 83 isemployable to regulate flow therethrough.

There is shown in FIGURE 14 of the illustrative drawings an alternativeclosure which includes a closure body 91 and a closure flange 92 whichare joined by a continuous, uninterrupted, annular rupturable portion93. The closure flange 92 is shown to be sealed to the port flange 43 ofthe closure assembly 36. If desired, the closure flange is of acharacter to be secured to the retainer 48 as shown in FIGURE 16 of theillustrative drawings. In this event the retainer 48 is securedthroughout its undersurface to the port flange 43. The closure body 91has formed integrally therewith an inwardly projecting supporting member91a, a terminal end 91b of which is in supporting contact with the portdiaphragm 250 for the purpose explained in reference to the constructionshown in FIGURE 7 of the illustrative drawings.

The closure 90 is preferably, although not necessarily, made in a moldsuch as a mold 94 of an injection molding machine (not shown). The mold94 is composed of a cavity block 95 and a cavity block 96. The cavityblock 95 is shown to be provided with a cavity 97. The cavity 97 has acavity portion 97a the outline of which forms the outer surface of theclosure body 91 and a cavity portion 9721 which forms the closure flange92. The cavity block 95 has a runner 98 which communicates directly withthe cavity portion 97a. The cavity block 95 has a bore 99 which opensinto a smaller bore 1%. The cavity block 96 is provided with a shoulder101 against which a core pin 102 is adapted to be seated. The core pin102 and an annular face 103 on the cavity block 96 form what may betermed the inner surfaces of the closure 90. The core pin 102 isprovided with a recess 1020 which forms the supporting member 91a Therupturable portion 93 is formed by a restriction 104 at the place wherethe cavity portions 97a and 97b of the cavity 97 meet. During themolding of the closure 90 an injection moldable material is passedthrough the runner 98 and directly into the cavity portion 97a After thecavity portion 97a has been filled the pressure exerted by the moldingmachine (not shown) forces the injection moldable material into thecavity portion 97b. A high degree. of stress is established at the placeof a restriction 104 so that not only isthe rupturable portion 93relatively thin but it is of character that is weak so that it can beruptured manually, although it is strong enough to withstand ordinaryhandling.

FIGURE 16 illustrates the manner in which the closure 90 appears beforeit has been ruptured while FIG- URE 17 illustrates the manner in whichthe closure 90 appears after the closure body 91 has been ruptured fromthe closure flange 92.

The outer surface of the closure body 91 is of a character to beroughened to assist the gripping thereof, as illustrated in FIGURE 18 ofthe illustrative drawings. Other ways of toughening a portion of theouter surface of the closure 90 .are also employable.

Referring now to FIGURE 19 of the illustrative drawings, there is shownan alternative form of hanger assembly generally indicated at 46A whichis identical in construction to the hanger assembly 46, save oneexception, namely that the effective length of a hanger 63a is less 9than the effective length of a hanger 64a. This simple constructionenables the transverse end of the bag 25 to be hung canted with respectto the tating the extraction of the plasma P, for example, from onecontainer 25 into another container like the container 25A. It isapparent from FIGURE 19 of the illustrative drawings that the effectivedistance of the hanger 63a from the transverse end 26 is less than theeffective distance of the hanger 64a from the transverse end 26.

Referring now to FIGURE of the illustrative drawings, there is shown ahanger assembly 46B which includes a pair of hangers 63b and 64b. Eachof the hangers 63b and 64b is secured for example by dielectric orchemical scaling to the transverse end 26 of the bag 25. The hanger 63bhas spaced apertures .110 and 111 while the hanger 64b has spacedapertures 112 and 113. When it is desired to hang the bag on theextractor 73 so that the port assembly 37 is at a higher elevation withrespect to the horizontal than is the port assembly 36, the hooks 75 and76 are passed through apertures 113 and 110, respectively, while whenthe port assembly 36 is desired to be disposed at a higher elevationwith respect to the horizontal than is the port assembly 37, the hooks75 and 76 are passed through the apertures 111 and 112, respectively.

The transverse end 27 of the bag 25 is shown to be provided with anaperture 114 near the longitudinal marginal side 28 while an aperture115 is disposed near the longitudinal marginal side 29. An aperture 116is disposed generally medially bet-ween the apertures 114 and 115, whileapertures 117 and .118 are disposed between the aperture 114 and theaperture 116 and between the aperture 116 and the aperture 115,respectively. A hanger assemblygenerally indicated at 119 includes apair of hangers 120 and 121. The hanger 120 has an aperture 122 whilethe hanger 121 has an aperture 123. The apertures 117 and 122 are shownto be generally longitudinally aligned, and the apertures 118 and 123are also shown to be generally longitudinally aligned. In the event thatthe bag 25 is to be supported in the position shown in FIGURE 8 of theillustrative drawings for the administration for example of whole bloodinto the patient, and the bag 25 is to be canted with respect to thehorizontal to afford efficient drainage, and two hooks similar to thehook 79 are to be employed, then one hook can be passed through theaperture 118 while the other of the hooks can be passed through theaperture 122. In this event the port assembly 36 will assume a lowerposition than will the port assembly 37. In the event that it is desiredto have the port assembly 37 at a lower position than the port assembly36 during the administration of whole blood or the like then the hooksare passed through the apertures 117 and 123.

In the event that a single hook, such as the hook 79, is to be employed,any one of the apertures 114, 115, 117, 118, 122 and 123 is employable.

Referring now to the embodiment of FIGURE 21 of the illustrativedrawings, there is shown a hanger assembly 460 provided withlongitudinally spaced apertures 125 and 126 at the longitudinal seal 31,while longitudinally spaced apertures 127 and 128 are provided at thelongitudinal seal 32. In the event that it is desired to dispose theport assembly 36 at a higher level than the port assembly 37 in theextractor 73, the hooks 75 and '76 are passed through the apertures 126and 127, respectively, while if it is desired to dispose the portassembly 37 at a higher level than the port assembly 36 in the extractor73, then the hooks 75 and '76 are passed through the apertures 123 and125, respectively.

At the transverse end 27 and near the longitudinal seal 31, there aredisposed longitudinally aligned apertures 129 and 130, while near thelongitudinal seal 32 there are disposed longitudinally aligned apertures131 and 132. An aperture 133 is disposed generally medially between theapertures 130 and 132. In the event that horizontal thereby facili- 10 aliquid, for example red cells RC, is to be administered and assuming twohorizontally aligned hooks such as the hook 79 are to be employed, thebag 25 shown in FIG- URE 21 of the illustrative drawings is disposed inthe same manner as is the bag 25 in FIGURE 8 of the illustrativedrawings. In the event the port assembly 36 is to be disposed at a lowerlevel than is the port assembly 37, one of the hooks is passed throughthe aperture 131 and the other of the hooks is passed through theaperture 130. If it is desired to dispose the port assembly 37 at alower level than the port assembly 36, then one of the hooks is passedthrough the aperture 129 and the other of the hooks is passed throughthe aperture 132.

The bag wall 25a of the bag 25 is constructable of any suitableflexible, heat sealable material of construction, for example polyvinylchloride, compatible with the liquid, for example parenteral solution,blood and the like which is adapted to be contained therein. The portassemblies 36, 37 and 38 are preferably formed by injection molding, anda plastic such as polyvinyl chloride is employable. The port assemblies36, 37 and 38 are composed of a heat sealable, flexible, extrudablethermoplastic material. The closures 6tl, 64, 64A, 64B and are of acharacter to be composed of plastics like polypropylene, nylon, vinyl,polycarbonate or polyethylene. The closure flanges 62 and 92 arepreferably relatively thin and flexible.

The above-described embodiments and method being exemplary only, it willbe understood that modifications in form, detail or procedure can bemade without departing from the spirit and scope of the invention.Accordingly, the invention is not to he considered as limited save as isconsonant with the scope of the following claims.

What is claimed is:

1. A bag unit for a parenteral solution comprising in combination: a baghaving a flexible bag wall, a port assembly including a tubular bodydefining a passage and a port flange securing said tubular body to saidbag wall, a closure received by said tubular body and having a closureflange seated against a portion of said port flange, and means securedto said port flange and overlying said closure flange for retaining saidclosure flange locked in removable seating engagement with said portflange and for preventing said closure flange from being reseated inunderlying relation to said retaining means.

2. For a bag having a flexible bag wall: a port assembly including atubular body defining a passage and a port flange for securing saidtubular body to said bag wall, a closure received by said tubular bodyand having a closure flange overlying a portion of said port flange, arelatively flexible retainer secured to said port flange and overlyingsaid closure flange, said retainer having an upstanding marginal flangeportion which embraces a portion of said closure, and means for urgingsaid upstanding marginal portion in hoop compression against saidclosure.

3. For a bag having a flexible bag wall: a port assembly including atubular body defining a passage and a port flange for securing saidtubular body to said bag wall, a closure received by said tubular bodyand having a flange overlying a portion of said port flange, a flexibleretainer secured to said port flange and overlying said flange of saidclosure, said retainer having an upstanding marginal flange portionwhich embraces a portion of said closure, a resilient ring encirclingsaid upstanding marginal portion.

4. For a bag having a flexible bag wall: a port assembly including atubular body defining a passage and a port flange for securing saidtubular body to said bag wall, a tube having a marginal portion and aterminal end, said marginal portion being received by said tubular body,a closure means disposed in said marginal end of said tube for closingoff communication through said tube, said closure means having a handleextending beyond the terminal end of the said tube and into the bag 1 1chamber to be gripped through the medium of the flexible bag wall forinsertion and removal.

5. A bag unit for a parenteral solution comprising in combination: a baghaving a flexible bag wall, a pair of spaced port assemblies eachincluding a tubular body defining a passage and a port flange securingthe tubular body to said bag wall, a closure received by each tubularbody and having a closure flange seated against a portion of arespective port flange, and means secured to said port flanges forretaining said closure flanges seated against the respective portflanges and for providing a bag supporting hanger assembly.

6. A bag unit for a parenteral solution comprising in combination: a baghaving a flexible bag wall, three spaced port assemblies each includinga tubular body defining a passage and a port flange securing saidtubular body to said bag wall, a hanger assembly having three spacedapertures therein, each of said apertures received by one of saidtubular bodies, said handle assembly being locally secured to each ofsaid port flanges,

7. A bag unit for a parenteral solution comprising in combination: asheath of flexible plastic material having generally rectangular shapeand defining two substantially like overlying faces connected at oneedge by the material, the faces of said sheath being secured to eachother along the other three edges to define a closed bag, the edgeopposite said one edge being adapted to support the bag pendulously withsaid one edge in down position, at least one port structure on saidsheath, said port structure being affixed to said sheath on said oneedge and being defined by finger-receiving plastic flanges on theoutside of the bag and straddling said one edge and a tube affixed tosaid flanges at said edge and extending outwardly from said edge, saidflanges being of dimension and material to support said tube inoutwardly extending position when sandwiched between the fingers andbeing on opposite sides of the extension of the lumen of said tube toshield the fingers from a pointed cannula extending through said tube,whereby with the said flanges held between the fingers a rigid cannulamay be inserted in the port tube and forced through the bag walladjacent thereto to provide a safe and sterile entry.

8. A bag unit for a parenteral solution comprising in combination: asheath of flexible plastic material having generally rectangular shapeand defining two substantially like overlying faces connected at oneedge by the material, the faces of said sheath being secured to eachother along the other three edges to define a closed bag, the edgeopposite said one edge being adapted to support the bag pendulously withsaid one edge in down position, at least one port structure on saidsheath, said port structure being afl'lxed to said sheath on said oneedge and being defined by finger-receiving plastic flanges on theoutside of the bag and straddling said one edge and a tube affixed tosaid flanges at said one edge and extending outwardly therefrom, adelivery tube sealingly secured to said one edge and extending into saidbag, said flanges being of dimension and material to separate said facesof said sheath proximate said delivery tube, whereby blood introducedinto said bag through said delivery tube will not wet the faces of thebag proximate said delivery tube thereby enabling the observation offlow rate through said delivery tube into said bag.

References Cited by the Examiner UNITED STATES PATENTS 2,323,629 7/43Spanel 8 X 2,777,490 1/57 Munk 150-8 2,838,046 6/58 Butler 128-2722,894,510 7/59 Bellamy 128-272 2,940,444 6/60 Beall 128-4214 2,969,1021/61 Cunningham 150.5 2,999,387 9/61 Andelin 128295 X 3,006,341 10/61Poitras 128214 3,022,613 2/62 Powers 5328 3,030,955 4/62 Gossett et a1.128-272 3,057,129 10/62 Meissner 53-28 3,073,307 1/63 Stevens 1282213,105,613 10/63 Barton et al. 128272 X 3,110,411 11/63 Golde 22039RICHARD A. GAUDET, Primary Examiner.

JORDAN FRANKLIN, Examiner.

UNITED STATES PATENT OFFICE CERTIFICATE OF CORRECTION Patent Non3,205,889 September 14, 1965 James E, Alder et al It is hereby certifiedthat error appears in the above numbered patent requiring correction andthat the said Letters Patent should read as corrected below.

Column 1, line 26, for "thbe" read tube column 5, line 16, strike out"48 and 50 are considered to form the opposed ends of"; column 6, line23, for "canot" read cannot column 7, line 23, for "illutsrative" readillustrative line 59, for "asembly" read assembly column 11, line l9,for "handle" read hanger Signed and sealed this 24th day of May 1966,

(SEAIJ Anna:

ERNEST W. SWIDER EDWARD J. BRENNER Attesting Officer Commissioner ofPatents

1. A BAG UNIT FOR A PARENTERAL SOLUTION COMPRISING IN COMBINATION: A BAGHAVING A FLEXIBLE BAG WALL, A PORT ASSEMBLY INCLUDING A TUBULAR BODYDEFINING A PASSAGE AND A PORT FLANGE SECURING SAID TUBULAR BODY TO SAIDBAG WALL, A CLOSURE RECEIVED BY SAID TUBULAR BODY AND HAVING A CLOSUREFLANGE SEATED AGAINST A PORTION OF SAID PORT FLANGE, AND MEANS SECUREDTO SAID PORT FLANGE AND OVERLYING SAID CLOSURE FLANGE FOR RETAINING SAIDCLOSURE FLANGE LOCKED IN REMOVABLE SEATING ENGAGEMENT WITH SAID PORTFLANGE AND FOR PREVENTING SAID CLOSURE FLANGE FROM BEING RESEATED INUNDERLYING RELATION TO SAID RETAINING MEANS.
 6. A BAG UNIT FOR APARENTERAL SOLUTION COMPRISING IN COMBINATION: A BAG HAVING A FLEXIBLEBAG WALL, THREE SPACED PORT ASSEMBLIES EACH INCLUDING A TUBULAR BODYDEFINING A PASSAGE AND A PORT FLANGE SECURING SAID TUBULAR BODY TO SAIDBAG WALL, A HANGER ASSEMBLY HAVING THREE SPACED APERTURES THEREIN, EACHOF SAID APERTURES RECEIVED BY ONE OF SAID TUBULAR BODIES, SAID HANDLEASSEMBLY BEING LOCALLY SECURED TO EACH OF SAID PORT FLANGES.